MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X12MM; CERVICAL SCREW

Catalog Number	03.70.273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 may 2019 lot 141342: (b)(4) items manufactured and released on 13-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, 22 items of the same lot have been already sold without any similar reported event.Two items of this lot have been involved in the current case, both for the same issue (breakage).Clinical evaluation performed by medical affairs director: this complaint reports no clinical damage and there is no clinical cause to it.Nothing to be recorded from the clinical point of view.Preliminary investigation performed by r&d project manager: based on the available information, it was understood that the screws head underwent to repeated high stress in order to easily advance in the vertebra.Also, the attempt to adjust the trajectory when inserted in the plate caused several potential stress on the heade screw.Following to the recommendation given in the surgical technique, the position of self-tapping screw can results critical step when not preparing the pilot-hole.Different from the self-drilling screws, the self-tapping screw design is not intended to create its own path because of the rounded design of the tip.
Event or Problem Description
During primary spine surgery was used a 2 level plate requiring 6 pieces of screws.The surgeon preferred the fixed self-drilling screws (length 12mm, 4,0mm diam.).On the leaner set were only 2 x 2 pieces of that size.Therefore he used the self-tapping screws of the same length and diameter.He used them in the same manner as the self-drilling screws without drilling and tapping.When the screw head approached the plate, the surgeon was not fully satisfied with the placement and tried to correct the screws by using the self-retaining screwdriver no.03.70.10.0032.This was also caused by the retractor in place influencing the angulation of the screw-instrument assembly and the screw trajectory.By using this instrument he exerted much-bending forces on the onto the self-retaining screwdriver that resulted on screw damage.The surgeon replaced the damaged screw by a 4,5mm recue screw of 12mm length and the surgery was successfully performed.The surgeon was satisfied.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: during the visual inspection on the retrieved screws it was observed and confirmed that some petals of the screw head were damaged.Additionally, it was noted that one m2 locking screws was fully separated from the bone screw.Most likely it happens during the removal, by using the extractor instrument.

• Brand Name: CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X12MM
• Common Device Name: CERVICAL SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8612048
• Report Number: 3005180920-2019-00367
• Device Sequence Number: 296221
• Product Code: KWQ
• UDI-Device Identifier: 07630030841309
• UDI-Public: 07630030841309
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 03.70.273
• Device Lot Number: 141342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 85